Amgen将在2026年AHA会上公布在高危患者中使用Repatha® (evolocumab降低低密度脂蛋白胆固醇（LDL-C）的最新数据

About the VESALIUS-CV Trial

VESALIUS-CV is a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with evolocumab on MACE in adults at high CV risk without prior heart attack or stroke. Results were published in the New England Journal of Medicine in November 2025. Repatha demonstrated a 25% relative reduction in the risk of a composite of coronary heart disease (CHD) death, heart attack or ischemic stroke (3-P MACE), and 19% reduction in a broader composite that also included any ischemia-driven arterial revascularization (4-P MACE). Repatha also reduced the risk of heart attack by 36%. In a lipid sub-study, adding Repatha to a maximally tolerated dose of statin and/or ezetimibe substantially lowered LDL-C levels among observed patients, with a median level of 45 mg/dL compared to 109 mg/dL in the placebo group.

VESALIUS-CV enrolled more than 12,000 patients with known ASCVD or high-risk diabetes, who had no history of heart attack or stroke, an LDL-C ≥ 90 mg/dL, or non-high-density lipoprotein cholesterol (non-HDL-C) ≥ 120 mg/dL, or apolipoprotein B ≥ 80 mg/dL; and treated with highest tolerated dose of statin and/or ezetimibe. The median baseline LDL-C was 122 mg/dL (IQR, 104-149 mg/dL). Participants were randomized to receive Repatha or placebo in addition to optimized lipid-lowering therapy and were followed for a median of approximately 4.6 years.

About the FOURIER Trial 

FOURIER was a Phase 3, double-blind, randomized, placebo-controlled, global clinical trial designed to evaluate the impact of LDL-C lowering with Repatha (evolocumab) on MACE in adults with established atherosclerotic cardiovascular disease.

FOURIER enrolled more than 27,000 patients with known ASCVD (history of myocardial infarction, nonhemorrhagic stroke or symptomatic peripheral artery disease) and LDL-C ≥70 mg/dL and/or non-HDL-C ≥100 mg/dL, despite high- or moderate-intensity statin therapy.

In the trial, Repatha reduced LDL-C levels by 59%, from a median baseline value of 92 mg/dL to 30 mg/dL (P<0.001). Repatha also significantly reduced the risk of major adverse cardiovascular events (MACE), including cardiovascular death, myocardial infarction, stroke, hospitalization for unstable angina or coronary revascularization (0.85; 95% CI, 0.79-0.92; P<0.001) by 15% and the composite of cardiovascular death, myocardial infarction or stroke (0.80; 95% CI, 0.73-0.88; P<0.001) by 20%. The results were consistent across key subgroups, including the subgroup of patients in the lowest quartile for baseline LDL-C levels (median, 74 mg/dL).

About the FOURIER-OLE Trial

FOURIER-OLE was the multicenter, open label extension (OLE) study designed to assess the long-term safety of Repatha (evolocumab) in subjects (adults with clinically evident ASCVD) who completed the Phase 3 FOURIER cardiovascular outcomes trial.

The OLE enrolled over 6,600 patients acrossEuropeandthe United Stateswho received Repatha for approximately 5 years, with some patients receiving Repatha for up to 8.4 years in aggregate across the FOURIER and OLE studies. Medically significant and sustained reduction in LDL-C levels were observed, with more than 85% of patients achieving an LDL-C level of <40 mg/dL during the OLE period. No new long-term safety findings were observed. FOURIER-OLE is the longest trial of PCSK9i monoclonal antibody (mAb) to date.

About Repatha

Repatha is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9). Repatha binds to PCSK9 and inhibits circulating PCSK9 from binding to the low-density lipoprotein (LDL) receptor (LDLR), preventing PCSK9-mediated LDLR degradation and permitting LDLR to recycle back to the liver cell surface. By inhibiting the binding of PCSK9 to LDLR, Repatha increases the number of LDLRs available to clear LDL from the blood, thereby lowering LDL-C levels.

Repatha is one of the most extensively studied PCSK9 inhibitors, with clinical and real-world evidence across diverse populations and CV risk profiles.4 The clinical benefits and safety of Repatha have been studied for 15 years in 51 clinical trials with over 57,000 patients.5 Repatha is the only PCSK9 inhibitor to demonstrate a significant reduction of cardiovascular events as both high-risk primary and secondary prevention, with patients achieving and maintaining dramatic LDL-C reductions using Repatha once every two weeks.6,7

Repatha was first approved in 2015 and has since been used by approximately 9 million patients globally.8 In August 2025, the U.S. Food and Drug Administration broadened the approved use of Repatha to include adults at increased risk for major adverse CV events due to uncontrolled LDL-C. InAugust 2026, theEuropean Commissionapproved an expanded indication for the use of Repatha in adults with established or high risk for ASCVD to reduce CV risk by lowering LDL-C levels, as an adjunct to correction of other risk factors, based on results from the Phase 3 VESALIUS-CV trial. Repatha is approved in 75 countries, including the U.S., Japan, Canada and in all 28 countries that are members of the European Union.9 Applications in other countries are pending. Repatha is the most covered PCSK9 inhibitor monoclonal antibody in theU.S.9 ~96% of patients are covered for Repatha across insurance types, with most patients paying less than$50/month.10 Through AmgenNow™, a direct-to-patient program, Repatha is available to patients at nearly 60% below the monthly list price.

About Amgen 

Amgen discovers, develops, manufactures and delivers innovative medicines to fight some of the world's toughest diseases. Harnessing the best of biology and technology, Amgen reaches millions of patients with its medicines.

More than 45 years ago, Amgen helped establish the biotechnology industry at its U.S. headquarters in Thousand Oaks, California, and it remains at the cutting edge of innovation, using technology and human genetic data to push beyond what is known today. Amgen is advancing a broad and deep pipeline and portfolio of medicines to treat cancer, heart disease, inflammatory conditions, rare diseases and obesity and obesity-related conditions.

Amgen has been consistently recognized for innovation and workplace culture, including honors from Fast Company and Forbes. Amgen is one of the 30 companies that comprise the Dow Jones Industrial Average®, and it is also part of the Nasdaq-100 Index®, which includes the largest and most innovative non-financial companies listed on the Nasdaq Stock Market based on market capitalization.